Coronary Artery DiseaseEVARESTNCT03674255
Echocardiography: Value and Accuracy at REst and STress
An observational study of Coronary Artery Disease and Ischaemic Heart Disease, run by University of Oxford.
Trial summary
EVAREST will identify and validate novel blood and imaging biomarkers of potential value for consistent and accurate interpretation of stress echocardiography. During phase one, blood samples will be collected to assess the impact of cardiac stress on levels of circulating biomarkers and examine whether the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Ischaemic Heart Disease, Angina Pectoris
- How many people
- 23,000 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Sep 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For phases 1 - 3, patients will be recruited when attending hospital for a stress echocardiogram to investigate the presence of ischaemic heart disease. For phase 4, patients attending hospital for a stress echocardiogram, for any investigation, will be recruited.
Who may be able to join
- Patients must be undergoing a stress echocardiogram to investigate the presence of ischaemic heart disease (groups 1-3).
- Patients must be able to provide informed consent.
- Patients must be aged over 18 years of age.
Who cannot join
- Patients undergoing stress echocardiography to assess valvular function.
- Patients who are unwilling or unable to provide informed consent.
- Patients aged under 18 years of age.
About this study
Official title: Use of Imaging and Blood Biomarkers to Improve the Diagnostic Accuracy of Cardiac Assessment by Stress Echocardiogram
EVAREST will identify and validate novel blood and imaging biomarkers of potential value for consistent and accurate interpretation of stress echocardiography. During phase one, blood samples will be collected to assess the impact of cardiac stress on levels of circulating biomarkers and examine whether the measurement of these biomarkers can provide additional prognostic information. Phases one, two and three will also determine whether novel imaging biomarkers can be identified in the echocardiograms that can be used for objective interpretation of the stress echocardiograms. EVAREST will recruit up to 8000 patients (First 500 during phase one, an additional 500 during phase two and an additional 7000 during phase three) from multiple hospitals across United Kingdom, who have been referred for a stress echocardiogram as part of their investigations into ischaemic heart disease. Phase four of the study will continue into a clinical study cohort phase to capture information from all patients referred for a stress echocardiogram in the UK, regardless of the reason for investigation.This registry phase will run for 2 years, recruiting up to 15000 participants.
Read the detailed description
Study Overview:
- Design
EVAREST is a multi-centre observational study comparing accuracy of novel quantitative stress echocardiography biomarkers for prediction of 12 month outcome against standard clinical interpretation.
- Scientific Justification
Coronary artery disease affects 2.3 million people in the UK and is responsible for 66 000 deaths each (BHF, 2018). As such, early diagnosis and intervention is crucial for saving lives and improving people's quality of life. Stress echocardiography is a commonly used, non-invasive imaging test used for detection of prognostically significant coronary artery disease. It allows the detection of regional wall motion abnormalities (RWMAs) which develop when the myocardium is not receiving adequate perfusion and, as such, indicates obstructive coronary artery disease. Average sensitivity and specificity for stress echocardiography is estimated at 81% and 82%, respectively (Geleijnse et al., 2009) in meta-analysis but remains highly subjective (Hoffmann et al., 1996) and subject to operator skill (Picano et al., 1991). Objective, quantifiable biomarkers in blood samples, or from images, acquired during the stress echocardiogram, which predict outcome of patients, could be used to reduce variability of stress echocardiography and ensure consistent and accurate results.
Aims
- To establish whether the measurement of specific blood biomarkers, in particular, extracellular vesicles, during a stress echocardiogram, can give additional prognostic information to stress echocardiography.
- To establish whether imaging biomarkers can provide additional prognostic information to stress echocardiography.
Phase One
Phase one will investigate the impact of cardiac stress on the levels of circulating biomarkers, in particular, extracellular vesicles. This phase will also assess whether they provide further prognostic information in addition to the echocardiogram. Blood samples will be collected from a cannula (inserted for the standard clinical procedure) before stress, during peak stress and during recovery and analysed to determine whether there were any changes in circulating extracellular vesicles during these three stages and whether these differ between patients with and without ischaemic heart disease.
Phase Two
Phase two continues recruitment for collection of stress echocardiogram images. Data collected during this phase will be compared with the data obtained during phase one to assess the usefulness of incorporating blood biomarkers into assessment of stress echocardiograms. In addition, the images obtained during phase two will be combined with the images collected during phase one to allow for the identification of novel imaging biomarkers which can be used to assist in the identification of patients with prognostically significant coronary disease.
Phase Three
Phase three will expand recruitment to allow evaluation of the generalisability of the imaging biomarkers identified in phase one and two across different healthcare settings, operators, stress protocols, machines and patient groups.
Phase Four
The fourth phase of the study allows for an assessment of all stress echocardiography practise in the UK and the demographics of patients being referred for stress echocardiogram. Phase four will investigate the use of stress echocardiography as a clinical procedure in the UK.
- Recruitment, Consent and Data Collection
Patients who have been scheduled a stress echocardiogram (using either pharmacological or exercise stress) as part of clinical investigations will be sent a participant information leaflet to read prior to their clinic appointment. When they are in the department, they will be approached by a study investigator to see whether they would be interested in taking part in the study and have the opportunity to ask the investigator any questions so that they fully understand the study. If they are interested in taking part, the process of obtaining informed consent will take place.
Following consent, the images acquired during the stress echocardiogram will be downloaded and anonymised with the participant's unique study ID number. These images will be transferred to the Oxford Research Echocardiography Core Laboratory (ORECL) for further analysis. Relevant medical history will be obtained for each participant as well as the clinician's interpretation of the echocardiogram. One year after the initial stress echocardiogram (range: 11-18 months), the participant will be followed-up to determine whether they underwent any further investigations for ischaemic heart disease (such as coronary angiography, cardiac magnetic resonance imaging, myocardial perfusion scintigraphy or repeat stress echocardiography) or had any coronary events. The participant may also be contacted via telephone to find out whether they were admitted to any other hospital for investigations. For phase one participants only, three blood samples (totalling approximately 40 ml) will be obtained before, at peak stress and after a recovery period, for the assessment of blood biomarkers. These samples will be taken through the cannula inserted as is routine during stress echocardiography. Participants will also give consent for follow-up information to be accessed for up to ten years after their initial stress echocardiogram.
- Outcome Assessment
Patient outcomes will be examined by an adjudication committee, blinded to the results of the stress echocardiograms. This committee will be led by a cardiologist and will examine all information obtained for a participant after the follow-up period has concluded. The criteria for confirming the presence of significant coronary artery disease include > 70% stenosis (assessed either via invasive coronary angiography or CT coronary angiography), an FFR < 0.85 or disease requiring intervention (either by percutaneous coronary intervention (PCI) or coronary artery bypass grafts (CABG)). Other end-points include coronary events (such as myocardial infarction) or death (attributed to coronary artery disease). If a patient has had no further investigations or events since their stress echocardiogram, their outcome will be recorded as normal.
- Confidentiality
All data obtained will be securely stored in accordance with the General Data Protection Regulations and Data Protection Act (2018) and Caldicott Principles.
- Keywords
- Stress Echocardiography, Blood Biomarkers, Extracellular Vesicles, Imaging Biomarkers, Machine Learning, Artificial Intelligence, Ischaemic Heart Disease, Coronary Artery Disease, Angina Pectoris
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Participants in group 1 will be recruited at their stress echocardiogram appointment. Anonymised versions of the stress echocardiograms will be obtained, in addition to venous blood samples obtained from the cannula inserted as part of the standard clinical procedure. These blood samples will be collected before and after the stress echocardiogram. These participants will be followed up by telephone call after one year to determine whether they had any additional cardiac tests or events outside of their hospital trust. Medical records relating to the participant will be reviewed annually for up to 10 years to identify if the patient has been admitted and obtain health outcome data. | |
| 2 | Participants in group 2 will be recruited at their stress echocardiogram appointment. Anonymised versions of the stress echocardiograms will be obtained. These participants will be followed up by telephone call after one year to determine whether they had any additional cardiac tests or events outside of their hospital trust. Medical records relating to the participant will be reviewed annually for up to 10 years to identify if the patient has been admitted and obtain health outcome data. | |
| 3 | Participants in group 3 will be recruited at their stress echocardiogram appointment. Anonymised versions of the stress echocardiograms will be obtained. These participants will be followed up by telephone call after one year to determine whether they had any additional cardiac tests or events outside of their hospital trust. Medical records relating to the participant will be reviewed annually for up to 10 years to identify if the patient has been admitted and obtain health outcome data. | |
| 4 | Participants in group 4 will be recruited at their stress echocardiogram appointment, regardless of the type of investigation. A simplified data set and an anonymised version of the stress echocardiography report will be collected as a part of this registry phase. Participants will be followed up over a 10-year period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Prognostically Significant CAD
Patients will be followed up one year after their stress echocardiogram to determine whether they have prognostically significant CAD. This is defined as >70% stenosis assessed by angiography (either via invasive coronary angiography or CT coronary angiography), an FFR< 0.85 or the intention to revascularize (either via PCI or CABG). Any tests that occur in a ten year period after the stress echocardiogram will also be recorded.
Measured: Data will be collected for ten years after the patient undergoes the stress echocardiogram.
Examination of Medical Records
Medical records will also be examined to check for any acute coronary syndromes within the year following the stress echocardiogram. Participants will also be contacted by telephone to capture any out-of-hospital events. Further follow-up data will be captured up to 10 years after the patient's initial stress echocardiogram.
Measured: Data will be collected for ten years after the patient undergoes the stress echocardiogram.
Secondary outcomes (4)
Quantification of Extracellular Vesicles (obtained from blood samples) by Flow Cytometry
The concentration of a comprehensive panel of cell-derived extracellular vesicles (such as erythrocyte, endothelial and platelet-derived extracellular vesicles) will be measured via flow cytometry in both the pre-stress and post-stress blood samples to assess the effect of cardiac stress on their concentration. The concentrations will also be compared between the patients with and without prognostically significant coronary artery disease to determine whether the concentration of extracellular vesicles is affected by coronary artery disease.
Measured: Blood samples will be obtained before and after the stress echocardiogram. Analysis will be complete one year from the date of the stress echocardiogram
Assessment of Time to Diagnosis
We will assess whether the use of novel imaging and blood biomarkers can reduce the time to diagnosis of prognostically significant CAD.
Measured: Data will be collected for ten years after the patient undergoes the stress echocardiogram.
Analysis of Potential Cost Savings Through the Use of Novel Biomarkers By the Reduction in Unnecessary Procedures
Health economic assessment will be carried out to determine whether the inclusion of imaging and blood biomarkers in the diagnostic process can ultimately lead to cost reductions through the reduction in unnecessary procedures and treatments.
Measured: Data will be collected for ten years after the patient undergoes the stress echocardiogram.
Investigation into the use of stress echocardiography as a clinical procedure in the UK.
Analysis of the number and type of stress echocardiograms performed across UK NHS sites as well as demographic information on the patients referred for stress echocardiography and accuracy of stress echocardiography, using follow-up data.
Measured: Data will be collected for ten years after the patient undergoes the stress echocardiogram.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study startMar 2015
- Primary completionMar 2021
- Study completionSep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, Royal United Hospital Bath NHS Trust, Tameside Hospital NHS Foundation Trust, Royal Berkshire NHS Foundation Trust, East Lancashire Hospitals NHS Trust, Bradford Teaching Hospitals NHS Foundation Trust, Calderdale and Huddersfield NHS Foundation Trust, Great Western Hospitals NHS Foundation Trust, Mid Essex Hospital NHS Trust, Buckinghamshire Healthcare NHS Trust, Wrightington, Wigan and Leigh NHS Foundation Trust, Chelsea and Westminster NHS Foundation Trust, Milton Keynes University Hospital NHS Foundation Trust, University Hospitals Bristol and Weston NHS Foundation Trust, North Middlesex University Hospital, Northumbria Healthcare NHS Foundation Trust, London North West Healthcare NHS Trust, St George's University Hospitals NHS Foundation Trust, Ultromics Ltd, National Institute for Health Research, United Kingdom, King's College Hospital NHS Trust, Guy's and St Thomas' NHS Foundation Trust, Poole Hospital NHS Foundation Trust, Blackpool Teaching Hospitals NHS Foundation Trust, Mid Yorkshire Teaching NHS Trust, Northampton General Hospital NHS Trust, North West Anglia NHS Foundation Trust, Yeovil District Hospital NHS Foundation Trust, East Suffolk and North Essex NHS Foundation Trust, Nottingham University Hospitals NHS Trust, Hampshire Hospitals NHS Foundation Trust, Lantheus Medical Imaging
- Responsible party
- Sponsor
- Investigators
- Paul Leeson, Principal investigator, Cardiovascular Clinical Research Facility, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674255
- Sponsor's protocol ID
- 18100
- Acronym
- EVAREST
- Status last verified
- Apr 2026
- First submitted
- 4 Sep 2018
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alsharqi M, Upton R, Mumith A, Leeson P. Artificial intelligence: a new clinical support tool for stress echocardiography. Expert Rev Med Devices. 2018 Aug;15(8):513-515. doi: 10.1080/17434440.2018.1497482. Epub 2018 Jul 19. No abstract available.
PubMed 29992841Augustine D, Ayers LV, Lima E, Newton L, Lewandowski AJ, Davis EF, Ferry B, Leeson P. Dynamic release and clearance of circulating microparticles during cardiac stress. Circ Res. 2014 Jan 3;114(1):109-13. doi: 10.1161/CIRCRESAHA.114.301904. Epub 2013 Oct 18.
PubMed 24141170Ayers L, Nieuwland R, Kohler M, Kraenkel N, Ferry B, Leeson P. Dynamic microvesicle release and clearance within the cardiovascular system: triggers and mechanisms. Clin Sci (Lond). 2015 Dec;129(11):915-31. doi: 10.1042/CS20140623.
PubMed 26359252
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Imaging and Blood Biomarkers to Improve the Diagnostic Accuracy of Cardiac Assessment by Stress Echocardiogram
- ClinicalTrials.gov ID
- NCT03674255
- Acronym / sponsor ID
- EVAREST / 18100
- Keywords
- Stress Echocardiography, Blood Biomarkers, Extracellular Vesicles, Imaging Biomarkers, Machine Learning, Artificial Intelligence, Ischaemic Heart Disease, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 23,000 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, Royal United Hospital Bath NHS Trust, Tameside Hospital NHS Foundation Trust, Royal Berkshire NHS Foundation Trust, East Lancashire Hospitals NHS Trust, Bradford Teaching Hospitals NHS Foundation Trust, Calderdale and Huddersfield NHS Foundation Trust, Great Western Hospitals NHS Foundation Trust, Mid Essex Hospital NHS Trust, Buckinghamshire Healthcare NHS Trust, Wrightington, Wigan and Leigh NHS Foundation Trust, Chelsea and Westminster NHS Foundation Trust, Milton Keynes University Hospital NHS Foundation Trust, University Hospitals Bristol and Weston NHS Foundation Trust, North Middlesex University Hospital, Northumbria Healthcare NHS Foundation Trust, London North West Healthcare NHS Trust, St George's University Hospitals NHS Foundation Trust, Ultromics Ltd, National Institute for Health Research, United Kingdom, King's College Hospital NHS Trust, Guy's and St Thomas' NHS Foundation Trust, Poole Hospital NHS Foundation Trust, Blackpool Teaching Hospitals NHS Foundation Trust, Mid Yorkshire Teaching NHS Trust, Northampton General Hospital NHS Trust, North West Anglia NHS Foundation Trust, Yeovil District Hospital NHS Foundation Trust, East Suffolk and North Essex NHS Foundation Trust, Nottingham University Hospitals NHS Trust, Hampshire Hospitals NHS Foundation Trust, Lantheus Medical Imaging
- Study start
- Mar 2015 (actual)
- Primary completion
- Mar 2021 (actual)
- Study completion
- Sep 2033 (estimated)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
EVAREST will identify and validate novel blood and imaging biomarkers of potential value for consistent and accurate interpretation of stress echocardiography. During phase one, blood samples will be collected to assess the impact of cardiac stress on levels of circulating biomarkers and examine whether the measurement of these biomarkers can provide additional prognostic information. Phases one, two and three will also determine whether novel imaging biomarkers can be identified in the echocardiograms that can be used for objective interpretation of the stress echocardiograms. EVAREST will recruit up to 8000 patients (First 500 during phase one, an additional 500 during phase two and an additional 7000 during phase three) from multiple hospitals across United Kingdom, who have been referred for a stress echocardiogram as part of their investigations into ischaemic heart disease. Phase four of the study will continue into a clinical study cohort phase to capture information from all patients referred for a stress echocardiogram in the UK, regardless of the reason for investigation.This registry phase will run for 2 years, recruiting up to 15000 participants.
Detailed description
Study Overview:
- Design
EVAREST is a multi-centre observational study comparing accuracy of novel quantitative stress echocardiography biomarkers for prediction of 12 month outcome against standard clinical interpretation.
- Scientific Justification
Coronary artery disease affects 2.3 million people in the UK and is responsible for 66 000 deaths each (BHF, 2018). As such, early diagnosis and intervention is crucial for saving lives and improving people's quality of life. Stress echocardiography is a commonly used, non-invasive imaging test used for detection of prognostically significant coronary artery disease. It allows the detection of regional wall motion abnormalities (RWMAs) which develop when the myocardium is not receiving adequate perfusion and, as such, indicates obstructive coronary artery disease. Average sensitivity and specificity for stress echocardiography is estimated at 81% and 82%, respectively (Geleijnse et al., 2009) in meta-analysis but remains highly subjective (Hoffmann et al., 1996) and subject to operator skill (Picano et al., 1991). Objective, quantifiable biomarkers in blood samples, or from images, acquired during the stress echocardiogram, which predict outcome of patients, could be used to reduce variability of stress echocardiography and ensure consistent and accurate results.
Aims
- To establish whether the measurement of specific blood biomarkers, in particular, extracellular vesicles, during a stress echocardiogram, can give additional prognostic information to stress echocardiography.
- To establish whether imaging biomarkers can provide additional prognostic information to stress echocardiography.
Phase One
Phase one will investigate the impact of cardiac stress on the levels of circulating biomarkers, in particular, extracellular vesicles. This phase will also assess whether they provide further prognostic information in addition to the echocardiogram. Blood samples will be collected from a cannula (inserted for the standard clinical procedure) before stress, during peak stress and during recovery and analysed to determine whether there were any changes in circulating extracellular vesicles during these three stages and whether these differ between patients with and without ischaemic heart disease.
Phase Two
Phase two continues recruitment for collection of stress echocardiogram images. Data collected during this phase will be compared with the data obtained during phase one to assess the usefulness of incorporating blood biomarkers into assessment of stress echocardiograms. In addition, the images obtained during phase two will be combined with the images collected during phase one to allow for the identification of novel imaging biomarkers which can be used to assist in the identification of patients with prognostically significant coronary disease.
Phase Three
Phase three will expand recruitment to allow evaluation of the generalisability of the imaging biomarkers identified in phase one and two across different healthcare settings, operators, stress protocols, machines and patient groups.
Phase Four
The fourth phase of the study allows for an assessment of all stress echocardiography practise in the UK and the demographics of patients being referred for stress echocardiogram. Phase four will investigate the use of stress echocardiography as a clinical procedure in the UK.
- Recruitment, Consent and Data Collection
Patients who have been scheduled a stress echocardiogram (using either pharmacological or exercise stress) as part of clinical investigations will be sent a participant information leaflet to read prior to their clinic appointment. When they are in the department, they will be approached by a study investigator to see whether they would be interested in taking part in the study and have the opportunity to ask the investigator any questions so that they fully understand the study. If they are interested in taking part, the process of obtaining informed consent will take place.
Following consent, the images acquired during the stress echocardiogram will be downloaded and anonymised with the participant's unique study ID number. These images will be transferred to the Oxford Research Echocardiography Core Laboratory (ORECL) for further analysis. Relevant medical history will be obtained for each participant as well as the clinician's interpretation of the echocardiogram. One year after the initial stress echocardiogram (range: 11-18 months), the participant will be followed-up to determine whether they underwent any further investigations for ischaemic heart disease (such as coronary angiography, cardiac magnetic resonance imaging, myocardial perfusion scintigraphy or repeat stress echocardiography) or had any coronary events. The participant may also be contacted via telephone to find out whether they were admitted to any other hospital for investigations. For phase one participants only, three blood samples (totalling approximately 40 ml) will be obtained before, at peak stress and after a recovery period, for the assessment of blood biomarkers. These samples will be taken through the cannula inserted as is routine during stress echocardiography. Participants will also give consent for follow-up information to be accessed for up to ten years after their initial stress echocardiogram.
- Outcome Assessment
Patient outcomes will be examined by an adjudication committee, blinded to the results of the stress echocardiograms. This committee will be led by a cardiologist and will examine all information obtained for a participant after the follow-up period has concluded. The criteria for confirming the presence of significant coronary artery disease include > 70% stenosis (assessed either via invasive coronary angiography or CT coronary angiography), an FFR < 0.85 or disease requiring intervention (either by percutaneous coronary intervention (PCI) or coronary artery bypass grafts (CABG)). Other end-points include coronary events (such as myocardial infarction) or death (attributed to coronary artery disease). If a patient has had no further investigations or events since their stress echocardiogram, their outcome will be recorded as normal.
- Confidentiality
All data obtained will be securely stored in accordance with the General Data Protection Regulations and Data Protection Act (2018) and Caldicott Principles.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Participants in group 1 will be recruited at their stress echocardiogram appointment. Anonymised versions of the stress echocardiograms will be obtained, in addition to venous blood samples obtained from the cannula inserted as part of the standard clinical procedure. These blood samples will be collected before and after the stress echocardiogram. These participants will be followed up by telephone call after one year to determine whether they had any additional cardiac tests or events outside of their hospital trust. Medical records relating to the participant will be reviewed annually for up to 10 years to identify if the patient has been admitted and obtain health outcome data. |
| 2 | – | –Participants in group 2 will be recruited at their stress echocardiogram appointment. Anonymised versions of the stress echocardiograms will be obtained. These participants will be followed up by telephone call after one year to determine whether they had any additional cardiac tests or events outside of their hospital trust. Medical records relating to the participant will be reviewed annually for up to 10 years to identify if the patient has been admitted and obtain health outcome data. |
| 3 | – | –Participants in group 3 will be recruited at their stress echocardiogram appointment. Anonymised versions of the stress echocardiograms will be obtained. These participants will be followed up by telephone call after one year to determine whether they had any additional cardiac tests or events outside of their hospital trust. Medical records relating to the participant will be reviewed annually for up to 10 years to identify if the patient has been admitted and obtain health outcome data. |
| 4 | – | –Participants in group 4 will be recruited at their stress echocardiogram appointment, regardless of the type of investigation. A simplified data set and an anonymised version of the stress echocardiography report will be collected as a part of this registry phase. Participants will be followed up over a 10-year period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For phases 1 - 3, patients will be recruited when attending hospital for a stress echocardiogram to investigate the presence of ischaemic heart disease. For phase 4, patients attending hospital for a stress echocardiogram, for any investigation, will be recruited.
Key inclusion criteria (3 listed)
- Patients must be undergoing a stress echocardiogram to investigate the presence of ischaemic heart disease (groups 1-3).
- Patients must be able to provide informed consent.
- Patients must be aged over 18 years of age.
Key exclusion criteria (3 listed)
- Patients undergoing stress echocardiography to assess valvular function.
- Patients who are unwilling or unable to provide informed consent.
- Patients aged under 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of Prognostically Significant CAD
Time frame: Data will be collected for ten years after the patient undergoes the stress echocardiogram.
Patients will be followed up one year after their stress echocardiogram to determine whether they have prognostically significant CAD. This is defined as >70% stenosis assessed by angiography (either via invasive coronary angiography or CT coronary angiography), an FFR< 0.85 or the intention to revascularize (either via PCI or CABG). Any tests that occur in a ten year period after the stress echocardiogram will also be recorded.
Examination of Medical Records
Time frame: Data will be collected for ten years after the patient undergoes the stress echocardiogram.
Medical records will also be examined to check for any acute coronary syndromes within the year following the stress echocardiogram. Participants will also be contacted by telephone to capture any out-of-hospital events. Further follow-up data will be captured up to 10 years after the patient's initial stress echocardiogram.
4 secondary outcomes
Quantification of Extracellular Vesicles (obtained from blood samples) by Flow Cytometry
Time frame: Blood samples will be obtained before and after the stress echocardiogram. Analysis will be complete one year from the date of the stress echocardiogram
Assessment of Time to Diagnosis
Time frame: Data will be collected for ten years after the patient undergoes the stress echocardiogram.
Analysis of Potential Cost Savings Through the Use of Novel Biomarkers By the Reduction in Unnecessary Procedures
Time frame: Data will be collected for ten years after the patient undergoes the stress echocardiogram.
Investigation into the use of stress echocardiography as a clinical procedure in the UK.
Time frame: Data will be collected for ten years after the patient undergoes the stress echocardiogram.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 29992841Alsharqi M, Upton R, Mumith A, Leeson P. Artificial intelligence: a new clinical support tool for stress echocardiography. Expert Rev Med Devices. 2018 Aug;15(8):513-515. doi: 10.1080/17434440.2018.1497482. Epub 2018 Jul 19. No abstract available.
- Background: PubMed 24141170Augustine D, Ayers LV, Lima E, Newton L, Lewandowski AJ, Davis EF, Ferry B, Leeson P. Dynamic release and clearance of circulating microparticles during cardiac stress. Circ Res. 2014 Jan 3;114(1):109-13. doi: 10.1161/CIRCRESAHA.114.301904. Epub 2013 Oct 18.
- Background: PubMed 26359252Ayers L, Nieuwland R, Kohler M, Kraenkel N, Ferry B, Leeson P. Dynamic microvesicle release and clearance within the cardiovascular system: triggers and mechanisms. Clin Sci (Lond). 2015 Dec;129(11):915-31. doi: 10.1042/CS20140623.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruitingObservational study
Assessment of Transnational Performance of the Universal Cardiac Surgical Risk Score Across International Sites
Heart Valve Diseases, Cardiac Surgical Procedures
Not yet recruiting
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Leeson principal investigator
Cardiovascular Clinical Research Facility, University of Oxford
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Ischaemic Heart Disease, run by University of Oxford.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Prognostically Significant CAD (time frame: Data will be collected for ten years after the patient undergoes the stress echocardiogram.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03674255, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.